NCT07651709

Brief Summary

This study is aimed to evaluate the efficacy of bone health management in improving pregnancy outcomes among WWE, and establish evidence-based vitamin D supplementation strategies for childbearing-age WWE.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
103mo left

Started Jun 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress2%
Jun 2026Jan 2035

First Submitted

Initial submission to the registry

April 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 16, 2026

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

June 16, 2026

Status Verified

April 1, 2026

Enrollment Period

8.6 years

First QC Date

April 17, 2026

Last Update Submit

June 11, 2026

Conditions

EpilepsyPregnant WomanBone Health

Keywords

epilepsypregnancy

Outcome Measures

Primary Outcomes (6)

  • Bone metabolisms indicators in offspring

    25-hydroxy Vitamin D (ng/ml)，procollagen type 1 N-terminal propeptide (P1NP, ng/ml),osteocalcin (OC, ng/ml)

    Childbirth

  • Bone metabolisms indicators in offspring

    Parathyroid hormone (PTH, ng/L)

    Childbirth

  • Bone metabolisms indicators in offspring

    β-crosslaps (β-CTX, pg/ml)

    Childbirth

  • Bone metabolisms indicators in offspring

    Body length(cm)

    Childbirth

  • Bone metabolisms indicators in offspring

    Weight(g)

    Childbirth

  • Bone metabolisms indicators in offspring

    Head circumference(cm)

    Childbirth

Secondary Outcomes (4)

  • Live birth rate without major congenital malformations (MCMs)

    The outcome will be assessed at two critical time points:At Birth (Day 0-7 Post-Delivery)，Within 30 Days Postnatal

  • Maternal Bone metabolisms indicators

    12, 24, and 36 weeks of pregnancy, the time during delivery

  • Maternal Bone metabolisms indicators

    12, 24, and 36 weeks of pregnancy, the time during delivery

  • Maternal Bone metabolisms indicators

    12, 24, and 36 weeks of pregnancy, the time during delivery

Study Arms (2)

calcium + vitamin D group

EXPERIMENTAL

Intervention for epilepsy patients

Drug: Supplementation with calcium + vitamin D daily.

standard of care group

NO INTERVENTION

Epilepsy patients receive normal follow-up without any intervention.

Interventions

Supplementation with calcium + vitamin D daily.DRUG

Test bone metabolism indicators at 10-14 weeks of pregnancy and intervene based on vitamin D levels. * For vitamin D levels \> 20 ng/ml: Supplementation with 725 mg of calcium + 500 IU of vitamin D daily. * For 10 ng/ml \< vitamin D levels ≤20 ng/ml: Supplementation with 725 mg of calcium + 900 IU of vitamin D daily. * For vitamin D levels ≤10 ng/ml: Supplementation with 725 mg of calcium + 1300 IU of vitamin D daily.

calcium + vitamin D group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of focal or generalized epilepsy as defined by the International League Against Epilepsy.
  • Women of childbearing age, aged ≥18 years, planning pregnancy or in early pregnancy (≤16 weeks gestation, confirmed by last menstrual period or ultrasound) - single pregnancy.
  • Willing and able to provide written informed consent.

You may not qualify if:

  • Pre-existing conditions affecting bone metabolism: primary hyperparathyroidism, Paget's disease, multiple myeloma, chronic kidney disease (eGFR \<60 mL/min), cirrhosis (Child-Pugh B/C), or untreated hyper/hypothyroidism.
  • History of metabolic complications: hypercalcemia (serum Ca²⁺ \>10.5 mg/dL), nephrolithiasis, or granulomatous diseases.
  • Recent/current use of bone-modifying drugs: bisphosphonates, glucocorticoids (≥5 mg/day prednisone equivalent for \>1 month), or loop diuretics within the past year.
  • Ultrasound shows fetal malformation.
  • Presence of other severe systemic diseases deemed unsuitable for study participation by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Dietary SupplementsCalcium

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Central Study Contacts

Jiajia Fang

CONTACT

15215880868fangjjiaj@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
pediatricians, lab researchers, statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2026

First Posted

June 16, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

January 1, 2035

Study Completion (Estimated)

January 1, 2035

Last Updated

June 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)